EGFR Positive Non-small Cell Lung CancerPhase 2NCT07322783
Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification
A Phase 2 study testing • Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets in people with EGFR Positive Non-small Cell Lung Cancer and MET Amplification, run by Qingdao Central Hospital at 1 site in China.
Trial summary
Osimertinib combined with savolitinib in the treatment of EGFR mutated osimertinib resistant NSCLC with low copy number MET amplification There are unmet medical needs in patients who resist to to osimertinib; savolitinib plus osimertinib shows high response rate and prolong progression-free survival in high copy… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- EGFR Positive Non-small Cell Lung Cancer, MET Amplification
- What is being tested?
- • Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histologically or cytologically confirmed incurable advanced or metastatic non-small cell lung cancer who resistant to resistant to osimertinib, chemo-immunotherapy or anti-angiogenesis.
- 2. At least 1 measurable lesion (RECIST 1.1). 3. MET amplification copy number below 5 by FISH. 4. Male or female patients age ≥18 years. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 6. Estimated OS ≥3 months. 7. Adequate hematologic and bone marrow functions. 8. Adequate renal and liver function. 9. Had recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study.
- 10. Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least three months following the last dose of study drug.
- 11. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).
- 12. Willingness and ability to comply with study procedures and follow-up examination.
- Exclusion13. Any of the following cardiac criteria: screening period resting period QTC > 470 milliseconds (clinical electrocardiograph report value; if a single time> 470 milliseconds, take the average of 3 inspections); rhythm of resting electrocardiogram (ECG), any clinically important abnormality of conduction or morphology (e.g., complete left bundle branch block, Grade 3 heart block, Grade 2 heart block); family history of congenital long QT prolongation syndrome or long QT syndrome.
Show all 12Show fewer
- 14. Evidence of any serious or uncontrolled systemic disease; various chronic active infections such as hepatitis B (HBV-DNA ≥ 104 copy number/ml or 2000 IU/ml), hepatitis C and HIV; uncontrollable Hypertensive patients (requires 2 or more drugs to control blood pressure); unstable angina; angina pectoris within 3 months prior to study; congestive heart failure (NYHA class II or higher); myocardial infarction (NSTEMI or STEMI) history in 6 months before study enrollment; severe arrhythmia requiring medical attention; severe liver, kidney, gastrointestinal or metabolic diseases.
- 15. Patients who are unable to taking drugs 16. Other malignancies need treatment; except effectively treated skin basal cell carcinoma, cutaneous squamous cell carcinoma, and/or effectively resected orthotopic cervical cancer and/or breast cancer.
- 17. Female patients during pregnancy or lactation. 18. Previous allergies or intolerance to treatment with osimertinib and savolitinib.
- 19. Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
- Criteria:
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qingdao Central Hospital
Qingdao, 266042
youxin ji, 8653268665078, kevinji78@yahoo.com
About this study
Official title: Osimertinib Combined With Savolitinib in the Treatment of EGFR Mutated Osimertinib Resistant NSCLC With Low Copy Number MET Amplification
Osimertinib combined with savolitinib in the treatment of EGFR mutated osimertinib resistant NSCLC with low copy number MET amplification There are unmet medical needs in patients who resist to to osimertinib; savolitinib plus osimertinib shows high response rate and prolong progression-free survival in high copy number MET amplification patients. This study is to explore the efficacy and safety of the combination of savolitinib and osimertinib in osimertinb resistant patients with low copy number MET amplification.
Read the detailed description
his is an open-label, single-arm, multicenter, phase 2 study. Low copy number MET amplification is defined as MET amplification copy number below 5 tested with NGS or FISH. All patients were 3rd or more lines therapy that had resistant to osimertinib, chemo-immunotherapy or anti-angiogenesis. Osimertinib mesylate tablets (hereinafter referred to as osimertinib) is 80 mg oral daily, savolitinib 400-600 mg (400mg for body weight <60 kg, 600 mg for body weight >60 kg) until disease progression or intolerable toxicities. Dose reduction of savolitinib can be from 600 mg to 400 mg and 400 mg to 200 mg.
- Being tested
- • Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets
- Keywords
- Savolitinib, Osimertinib, Drug Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• Drug: Savolitinib • Drug: Osimertinib Mesylate TabletsDrug
Osimertinib 80 mg oral daily, savolitinib 400-600 mg (400mg for body weight <60 kg, 600 mg for body weight >60 kg) until disease progression or intolerable toxicities. Dose reduction of savolitinib can be from 600 mg to 400 mg and 400 mg to 200 mg.
| Study group | Role | What they receive |
|---|---|---|
| Savolitinib plus osimertinib | Experimental | Not described Receives: Drug: • Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Overall response rate defined as the percentage of patients getting partial response and complete response after treatment
Measured: the percentage of patients getting partial response and complete response, assessed at 2 month.
Secondary outcomes (1)
Progression-free survival (PFS)
Progression-free survival is defined as the time from the date of enrollment to the date of disease progression or patient death from any cause.
Measured: From date of enrollment until the date of disease progression of patient death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Positive Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youxin Ji, Qingdao Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322783
- Sponsor's protocol ID
- KY202512203
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osimertinib Combined With Savolitinib in the Treatment of EGFR Mutated Osimertinib Resistant NSCLC With Low Copy Number MET Amplification
- ClinicalTrials.gov ID
- NCT07322783
- Acronym / sponsor ID
- KY202512203
- Keywords
- Savolitinib, Osimertinib, Drug Resistant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osimertinib combined with savolitinib in the treatment of EGFR mutated osimertinib resistant NSCLC with low copy number MET amplification There are unmet medical needs in patients who resist to to osimertinib; savolitinib plus osimertinib shows high response rate and prolong progression-free survival in high copy number MET amplification patients. This study is to explore the efficacy and safety of the combination of savolitinib and osimertinib in osimertinb resistant patients with low copy number MET amplification.
Detailed description
his is an open-label, single-arm, multicenter, phase 2 study. Low copy number MET amplification is defined as MET amplification copy number below 5 tested with NGS or FISH. All patients were 3rd or more lines therapy that had resistant to osimertinib, chemo-immunotherapy or anti-angiogenesis. Osimertinib mesylate tablets (hereinafter referred to as osimertinib) is 80 mg oral daily, savolitinib 400-600 mg (400mg for body weight <60 kg, 600 mg for body weight >60 kg) until disease progression or intolerable toxicities. Dose reduction of savolitinib can be from 600 mg to 400 mg and 400 mg to 200 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Savolitinib plus osimertinib | Experimental | Drug: • Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Histologically or cytologically confirmed incurable advanced or metastatic non-small cell lung cancer who resistant to resistant to osimertinib, chemo-immunotherapy or anti-angiogenesis.
- 2. At least 1 measurable lesion (RECIST 1.1). 3. MET amplification copy number below 5 by FISH. 4. Male or female patients age ≥18 years. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 6. Estimated OS ≥3 months. 7. Adequate hematologic and bone marrow functions. 8. Adequate renal and liver function. 9. Had recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study.
- 10. Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least three months following the last dose of study drug.
- 11. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).
- 12. Willingness and ability to comply with study procedures and follow-up examination.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| • Drug: Savolitinib • Drug: Osimertinib Mesylate TabletsOsimertinib 80 mg oral daily, savolitinib 400-600 mg (400mg for body weight <60 kg, 600 mg for body weight >60 kg) until disease progression or intolerable toxicities. Dose reduction of savolitinib can be from 600 mg to 400 mg and 400 mg to 200 mg. | Drug | Savolitinib plus osimertinib |
Primary outcome
Overall response rate (ORR)
Time frame: the percentage of patients getting partial response and complete response, assessed at 2 month.
Overall response rate defined as the percentage of patients getting partial response and complete response after treatment
1 secondary outcome
Progression-free survival (PFS)
Time frame: From date of enrollment until the date of disease progression of patient death from any cause, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing • Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets in people with EGFR Positive Non-small Cell Lung Cancer and MET Amplification, run by Qingdao Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact youxin Ji, md, phD (1718865657, kevinji78@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: the percentage of patients getting partial response and complete response, assessed at 2 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.